FDA DeviceClass IINotable

FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC

Date: 2026-04-08
Brand: Mentor Texas, LP.
Category: Medical Device
FDA Class: Class II

Description

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

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